Eliana Sandler
Manager, CMC Regulatory Scientific Writing
- Role
- Manager, Cmc Regulatory Scientific Writing at AstraZeneca
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
Experience
Manager, Cmc Regulatory Scientific Writing
Jun 2022 — Present · Gaithersburg, MD, US
Lead for the preparation of CMC (Chemistry, Manufacturing and Controls) regulatory documents for global clinical trial applications, marketing applications, and agency interactions (Biologic and some CAR-T products).Led the health authority interactions and regulatory defense for Beyfortus CMC BLA/MAA, resulting in the product\'s commercial approval for the US, EU, and wave 1 counties
Education
Muhlenberg College
Anthropology, Biomedical
2006 — 2010
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